Constipation is a common problem in intensive care units. We assessed the
efficacy and safety of laxative therapy aiming to promote daily defecation in
reducing organ dysfunction in mechanically ventilated patients.
conducted a prospective, randomized, controlled, nonblinded phase II clinical
trial at two general intensive care units. Patients expected to remain
ventilated for over 3 days were randomly assigned to daily defecation or
control groups. The intervention group received lactulose and enemas to produce
1–2 defecations per day. In the control group, absence of defecation was
tolerated up to 5 days. Primary outcome was the change in Sequential Organ
Failure Assessment (SOFA) score between the date of enrollment and intensive
care unit discharge, death or day 14. Results: We included 88 patients.
Patients in the treatment group had a higher number of defecations per day (1.3
± 0.42 versus 0.7 ± 0.56, p < 0.0001) and lower percentage of days without
defecation (33.1 ± 15.7 % versus 62.3 ±24.5 %, p < 0.0001). Patients in the
intervention group had a greater reduction in SOFA score (–4.0 (–6.0 to 0)
versus –1.0 (–4.0 to 1.0), p = 0.036) with no difference in mortality rates or
in survival time. Adverse events were more frequent in the treatment group (4.5
(3.0–8.0) versus 3.0 (1.0–5.7), p = 0.016), including more days with diarrhea
(2.0 (1.0–4.0) versus 1.0 (0–2.0) days, p < 0.0001). Serious adverse events
were rare and did not significantly differ between groups. Conclusions:
Laxative therapy improved daily defecation in ventilated patients and was
associated with a greater reduction in SOFA score.